Regulation (EU) 2019/6 of the European Parliament and of the Council of 11 December 2018 on veterinary medicinal products and repealing Directive 2001/82/EC (Text with EEA relevance) (c. 6)

CHAPTER III U.K. PROCEDURES FOR MARKETING AUTHORISATIONS

Section 2 U.K. Marketing authorisations valid in a single Member State (‘national marketing authorisations’)

Article 46 U.K. Scope of national marketing authorisation

1. An application for a national marketing authorisation shall be submitted to the competent authority in the Member State for which the authorisation is applied. The competent authority shall grant a national marketing authorisation in accordance with this Section and applicable national provisions. A national marketing authorisation shall be valid only in the Member State of the competent authority which granted it.

2. National marketing authorisations shall not be granted in respect of veterinary medicinal products which fall within the scope of Article 42(2), or for which a national marketing authorisation has been granted, or for which an application for a national marketing authorisation is pending in another Member State at the time of the application.

Article 47 U.K. Procedure for national marketing authorisation

1. The procedure for granting or refusing a national marketing authorisation for a veterinary medicinal product shall be completed within a maximum of 210 days of the submission of the valid application.

2. The competent authority shall prepare an assessment report containing the information referred to in Article 33.

3. The competent authority shall make the assessment report publicly available, after deleting any commercially confidential information.